USPTO Patents Application 10007393

Application No. 10/007^93
PfcUminaty Amendment Siibmined With RCE Application
Reply to Ofllce Action Mailed 05/09/2007

Amendments to the Drawings:

The attached sheet of drawings includes changes to Fig. 4, 5 and 6. These
drawing sheets, which includes Figs. 4, 5 and 6, completely replace the original sheets
including Figs 4, 5 and 6. In these Figs., omitted elements 40 and 40' have been added.
In addition, some of the wording has changed within the drawings.

Attachment: Replacement Sheet

Annotated Sheet Showing Changes

Page 10 of 21

Applicafion No. 10/007;593
Preltminajy Amendment Submined With RCE Application
Reply to OfTice Action Mailed 05/09/2007

REMARKS AND ARGUMENTS

Claims 2-1 1 and 14-19 have been canceled. Claims 1, 12, 13, aud 20-72 are now
pending in the application and presented for examination.

Claims 1, 12, and 13 are currently amended. Claims 20-72 are new.

The Examiners are thanked for having graciously held a telephone interview with
the undei^igned on October 4, 2007.

As mentioned in the interview, in a bona fide attempt to advance the application
to allowance and better understand the prior art cited by the Examiner that jelates to
devices for veterinary use. Applicants sought the assistance of a registered patent attorney
who is also a licensed veterinarian. The amendments and new claims presented here
were not presented earlier because they reflect the recently-received assistance of this
individual.

Reconsideration of die outstanding objections and rejections is respectfully
requested for the reasons tihat follow.

Drawings

The drawings were objected to under 37 CFR § L83(a) for failing to show every
feature of the invention specified in the claims. Specifically, the Examiner noted that an
"antenna" as claimed in claims 1, 14, and 16-19 was not shown in the drawings.

Three replacement drawing sheets in compliance with 37 CFR § 1.121(d) are
submitted herewith. Replacement Figures 4, 5, and 6 each show an antenna (40) as an
element of the probe unit and an antenna (40') as m element of the control unit.

No new matter has been entered as a result of these amendments. Support for an
antenna as an element of the probe unit appears in the original specification at least on
page 6 at lines 13-15 ("The stimulator unit 21 is furthermore provided with an
antenna"), and support for an antenna as an element of both the probe unit and the control
unit appears in the original specification at least on page 8 at lines 14-17 ("In particular,
the stimulator unit 21 and control unit 22 respectively include ... a transceiver 36, 36*
which includes an antenna.**).

Applicants have amended the specification concurrently to include the reference
characters of the antenna elements shown m the replacement drawings.

Page 11 of 21

Application No. ) 0/007^93
Preiiminaiy Amcndmcm Subtnined With RCH Application
Reply 10 Oiltce Action Moiled 05AK)!/2007

Additionally, in each of the replacement drawing sheets, "I.C.*' has been deleted
firdm the kbel of th6 ffejirfisentetidii 6f the miCf6j)r6CesS6f (35) of the probfe uiiit (21)
because this part of the label was not sufficiently explained in the written description.

Applicants respectfully request that the original three sheets of drawings for
Figures 4, 5, and 6 be replaced with the attached three replacement drawing sheets for
Figures 4, 5, and 6, and that the objections to the drawings be withdrawn.

Claim Rejections - 35 USC § 112

A. Rejections Under 35 USC § 112, First Paragraph

Claims 16-19 were rejected under 35 U.S.C. § 112, first paragraph, as failing to
comply with the written description requirement. Specifically, the Examiner stated that
the original disclosure of the application failed to provide support in fiill, clear, concise,
and exact terms that the combination probe, transceiver, and power source is (a) non-
expandable and non-compressible in cross-section, or (b) insertable into a vagina without
the use of a tool.

Applicants have now canceled claims 16-19. The limitations identified by the
Examiner as insufficiently supported are not recited in any currently pending claims.
Applicants respectfully submit, therefore, that this rejection is moot and request its
withdrawal.

B. Rejections Under 35 USC § 112, Second Paragraph

Claims 1-13, 16, 17, and 19 were rejected under 35 U.S.C. § 112, second
paragraph, as being indefinite for failing to particularly point out and distinctly claim the
subject matter which Applicants regard as the invention. In particular, the Examiner
stated that the limitation "non-implanted" recited in claims 1 and 16 rendered the claims
indefinite.

Applicants continue to respectfully tmverse this rejection and disagree with the
Examiner that the limitation "non-implanted** is indefinite, for reasons detailed in
previous communications. However, in an effort to advance the prosecution of the
application. Applicants have canceled claims 2-1 1, 16, 17, and 19, and amended claim I
to delete the limitation **non-tmplanted.*'

Page 12 of 21

Appttcaiion No. IO/007;593
Prctiminaty Amendmcm Submined With RCE Application
Reply to Ofllce Action Mailed 05/09/2007

This limitation is not now recited in any currently pending claim. Applicants
respectfully submit, therefore, thdt thi$ rejection h moot dnd re<)ue$t its withdrawdl, dhd
they respectfully request reconsideration of amended claims 1,12, and 13.

Claim Rejections 35 USC § 102

A. Anticipation By Mehrotm et al

Claims 1-7, 1 1-13, 16, 17, and 19 were rejected under 35 U.S,C. § 102(e) as being
anticipated by Mehrotra et al. (U.S. Pat. No. 6,860,859).

Applicants respectfully disagree with the Examiner, but to advance the
prosecution of the application, have now canceled claims 2-7, 11, 16, 17, and 19. Claim
1, and thus its dependent claims 12 and 13, has been amended to require, among other
things, that the system claimed comprises a combination probe provided with means for
stimulating perineal musculature and/or nerves.

Applicants respectfully submit that Mehrotra does not teach or suggest a vaginal
probe provided with means for stimulating perineal musculature and/or nerves.
Accordingly, Mehrotra does not describe every element of the Applicants' invention and
thus Applicants respectfully request that the rejection be withdrawn and amended claims
1,12, and 13 be reconsidered.

Claim 1, and thus its dependent claims 12 and 13, also has been amended to

require that the system claimed comprises a combination probe adapted to be entirely

contained within a human's own vagina. Applicants respectfully disagree with the

Examiner that Mehrotra teaches an intravaginally containable combination probe which

integrates a transceiver, an antenna, and a power source. Mehrotra describes only devices

that are partially intravaginally containable, with any signal transmitting means of these

devices located on the portions of the devices that are outside the mammal's body and not

contained within die vagina. Mehrotra repeatedly teaches that the communication means

of the described device should not be contained within the vagina, as can be seen in

Figure 2 and the verbal examples here:

• "said transmitting means being suitable to be held in continuous proximity
to the mammal's body during the time of said measuring, converting and
transmitting, of the signal" (column 3, lines 24-27);

Page 13 of 21

Application No. 10/0073W
Preliminary Amendment Submined Wiih RCK Applicarion
Reply to Office Action Mailed 05/09/2007

• "when the housing is within the mammars vagina, said sending means is
substantially external and proximal with respect to the mammal's body"
(column 3, lines 34-37);

• *The extension being of such dimension and position on the apparatus so as
to provide for a portion which is exterior to the mammal when the apparatus
is inserted into the mammals [sic] vagina." (column 4, lines 3-6);

• 'The sensed condition, data or information is transmitted as signals
(electronic or otherwise) representing each of said conditions from a
location proximal and exterior to the mammars body." (column 5, lines 9-
12).

Although Mehrotra does not disclose why the communication means should not
be contained within the vagina, Applicants believe the reason to be that Mehrotra's
communication means could not function adequately when so contained because of the
significant attenuation and distortion of wireless signal transmission and reception
imposed by a mammalian body. This signal attenuation and distortion was a problem in
the prior art that Applicants' invention has overcome. Mehrotra does not teach or suggest
how to overcome this problem and would have had no reasonable expectation of success
in overcoming it, and thus Mehrotra does not teach or suggest a combination probe such
as the Applicants claim that has a transceiver capable of functioning wirelessly in real
time while entirely contained within a mammaPs vagina. Mehrotra's apparatus is only
partially intravaginally containable, and Applicants believe that the apparatus Mehrotra
describes could not function if the signal transmitting means of the apparatus was
contained within a vagina.

Accordingly, Applicants respectfully request withdrawal of the rejection of claims
under 35 U.S.C. § 102(e) as being anticipated by Mehrotra et al. because Mehrotra fails
to describe each and every element of Applicants' claims. Applicants respectfully
request that amended claims 1, 12, and 13 be reconsidered.

B. Anticipation By Guice et al

Claims 1-7, 11-13, and 16 were rejected under 35 U.S.C. § 102(e) as being
anticipated by Guice et al. (U.S. Pat. Appl. Pub. No. US 2002/0010390).

Page 14 of 21

Applicaiion No. 10/007393
Prcitminaty Atncndmcm Submined With RCi: Appltcarion
Reply to Office Aclion Mailed 05/09/2007

Although Applicants respectfully disagree with the Examiner, in an effort to
advance the pfosecutioii of the ipplieatioft, claims 2-7, 11, and 16 have been canceled,
and claim 1, and thus its dependent claims 12 and 13, has been amended.

Claim 1, and thus its dependent claims 12 and 13, has been amended to require,
among other things, that the system claimed comprises a combination probe provided
with means for stimulating perineal musculature and/or nerves. Applicants respectfully
submit that Guice does not teach or suggest a vaginal probe provided with means for
stimulating perineal musculature and/or nerves or for affecting any vaginal condition.
Accordingly, Guice does not describe each and every element of the Applicants*
invention and Applicants respectfully request withdrawal of the rejection and
reconsideration of amended claims 1, 12, and 13.

Additionally, claim 1, and thus its dependent claims 12 and 13, has been amended
to emphasize, among other things, that the system claimed comprises a probe provided
with two-way communication means and a controller provided with means for sending
signals to the probe and for receiving signals therefrom wirelessly and in real time,
wherein a wireless signal feedback loop is provided between the controller and the probe
in real time during operation of the system. Applicants respectfully disagree with tlie
Examiner that Guice discloses a wireless signal feedback loop between the controller and
the probe and submit that any back-and-forth wireless transmissions that may occur
between components of Guice's system do not occur in real time. The paragraph
identified by the Examiner as supporting this disclosure, [0209], clearly indicates that the
disclosed control unit can only either transmit or receive wireless signals at any particular
point in time, as with "voice walkie-talkies and other personal radio devices," and cannot
both transmit and receive signals at the same time. The type of communication Guice
discloses is not wireless real-time two-way communication. Nowhere does Guice teach
or suggest wireless real-time two-way communications between a controller and a probe
such that a wireless signal feedback loop is provided in real time during operation of the
system.

Accordingly, Guice does not describe each and every element of the Applicants'
invention and Applicants respectfully request withdrawal of the rejection and
reconsideration of amended claims 1, 12, and 13.

Page 15 of 21

Applicalion No, JO/007,393
Preliminary Amendment Submincd Whh RCK Application
Reply 10 Office Action Mailed 05/09^2007

Claim Rejections - 35 USC § 103

A. Unpatentability Over Eini et ai In View Of Mehrotra et aL

Claims 8-10 were rejected under 35 U.SC § 103(a) as being unpatentable over
Eini et al. (U.S. Pat No. 6,432,037) in view of Mehrotra et al. (U.S. Pat. No. 6,860,859).

Claims 8-10 have been canceled. Applicants respectfiiUy request witlidrawal of
this rejection, therefore, because it is now moot.

B. Unpatentability Over BIythe In Vien OfMehrotra et aL

Claims 1-7 and 11-19 were rejected under 35 U.S.C. § 103(a) as being
unpatentable over BIythe (U.S. Pat. No. 6,080,1 18) in view of Mehrotra et al. (U.S. Pat.
No. 6,860,859).

In an effort to advance the prosecution of the application, claims 2-7, 1 1, and 14-
19 have been canceled. Claims 1, 12, and 13 have been amended to require, among other
things, that the system claimed comprises a combination probe adapted to be entirely
contained within a human's own vagina.

Applicants respectfully disagree with the Examiner that BIythe teaches an
intravaginally containable combination probe and power source. Blytlie describes a
vaginal probe having two ends: an insertable end portion and an external end portion.
BIythe teaches that a battery may be included in the external end portion only, BIythe
discloses that "[i]n use, the insertable end portion 14 of the probe 10 is inserted into the
subject's vagina 20 ... with the external end portion 16 maintained external to the
patient.'' Column 7, lines 38-42. BIythe does not teach or suggest a probe including a
power source that is containable within a vagina. The portion of Blythe's probe that is
intended for insertion into a vagina does not include a power source; the portion of
Blythe's probe that may include a power source is not intravaginally containable.

Moreover, as the Examiner admiued, BIythe fails to disclose a transceiver in
either the probe unit or the controller unit.

Mehrotra et al. does not teach or suggest the elements of Applicants' claims that
BIythe fails to describe. As discussed above, Mehrotra describes only devices having

Page 16 of 21

Application No, JO/007393
Preliminary Amendment Submincd With RCE Application
Reply to Oflicc Action Mailed 05/091/2007

signal transmitting means that are, by functional necessity, located outside a mammal's
body dufiiig the time of measuring and transmitting tO a receiving Station, Se^, e.g., Fig.
2, Mehrotra does not teach or suggest how to overcome the significant attenuation and
distortion of wireless signal transmission and reception that is imposed by a mammalian
body and would have had no reasonable expectation of success in overcoming it, and thus
does not teach or suggest a combination probe capable of functioning while entirely
contained within a mammars vagina as Applicants claim. Mehrotra's apparatus, like
Blythe's, is only partially intravaginally containable, and thus Applicants submit that not
only do neither Dlythe nor Mehrotra disclose an intravaginally containable probe with
two-way communication means, but neither of the devices described by Blythe and
Mehrotra could function adequately if their signal transmitting means were contained
within a vagina.

Accordingly, Applicants respectfully request withdrawal of the rejection and
reconsideration of amended claims 1, 12, and 13.

Additional Remarks Supporting Amendments and New Claims

A. Support for Limitations Appearing in Claims for the First Time

In an effort to assist the Examiner in examining the amended and numerous new
claims submitted herewith, Applicants agreed in the telephone interview of October 4,
2007, to point out at least some places where support can be found for certain limitations
appearing in the claims of this application for the first time.

Claim 1 has been amended to require that the combination probe is substantially
cylindrical. Support for this limitation can be found at least in the drawing of an
embodiment of the combination probe (21) in Figure I.

Claim 1 has been amended also to require that the combination probe has a
substantially smooth and substantially sealed outer surface. In addition to Figure 1
showing such an outer surface on the combination probe depicted therein, support for
these limitations can be found in the written description at least on page 3 at lines 20-21
("The probe of the inventive system contains no wires or similar external means or

Pagcl7of2l

Application No. 10/007,393
Ffeitminary Amendmcm Submined With RCK Application
Reply 10 OfTice Action Mailed 05/09/2007

surface controls'') and on page 1 1 at lines 6-7 C*the combination prok^ and transceiver
umt21 isdSedkd uiiit'').

Applicants have amended claim 1 to emphasize that the combination probe
claimed is adapted to be entirely contained within a human's own vagina. Support for
this amendment can be found in the original specification at least at page 3, lines 2-3
("portable, non-implanted, intravaginally containable (i.e. in situ yet removable)") and at
the last line of page 6 and first line of page 7 ("The stimulator unit 21 is then inserted into
the vagina."). That the probe can be entirely contained within a vagina is also evident by
the disclosure in the original specification, at page 6, lines 3-6, of an embodiment having
an end "rounded to facilitate vaginal insertion" and an opposite end that "can be provided
with, for example, an eyelet 25 to which a cord or similar device can be attached to
facilitate removal of the reusable unit." Applicants respectfiiUy submit that a probe such
as those described by Mehrotra et al, Blythe, and Eini et al. would have no use for a
means to facilitate removal from a vagina because a portion of each of those probes of the
prior art always remains external to the vagina and thus accessible to be readily grasped
and removed.

Additionally, that the probe claimed in amended claim 1 is adapted to be
contained within a human's own vagina is supported at least by the first paragraph on
page 4 of the original specification: "When the probe unit of the inventive system is used
as a stimulation unit, women are provided a safe, easy and convenient way to strengthen
and tone their pelvic muscles without professional intervention or special training." The
last paragraph on page 3 lends further support: "The probe of the inventive system
contains no wires or similar external means or surface controls, and is therefore
comfortable to use."

Amended claim 1 also requires that the combination probe is adapted to
ergonomically insert into and be removed from a human's own vagina. The support
mentioned above for the limitation that the probe is adapted to be entirely contained
within a vagina supports these limitations. Additionally, support for these limitations can
be found at least on page 1 1 at line 3, referring to the "ergonomic character of the probe,"
and on page 8 at lines 1 -2 ("The stimulator unit 21 can then be removed.")-

Page 18 of 21

Application No. IO/007;?93
Preiiminofy Amcndmcni Submincd With RCK Application
Reply lo Ofltce Action Mailed 05/09/2007

New claim 48 requires that the probe unit be adapted to be comfortably,
temporarily, repeatedly inserted into, cont^iihed entirely withiii, and removed from a
user's vagina. The portions of the specification identified above as supporting the
amendments to claim 1 also support these limitations of claim 48. Additional support for
these limitations is provided by the following examples from the specification:

• page 4 at lines 16-18 ("physiological information can be wirelessly tracked and
monitored, allowing observation and supervision of metabolic and fertility
activities'*);

• page 6 at line 1 9 ("To begin a session

• page 8 at lines 3-4 ("a session . . . could run for approximately 15 minutes");

• page 8 at lines 8-9 C*The stimulator unit 21 can be programmed so that it will
automatically ramp up to the setting of a previous use").

New claim 32 requires that the probe unit be so dimensioned as to permit
comfortable and repeated insertion into, removal from, and containment entirely within a
mammal's vagina. The portions of the specification identified above as supporting
amended claim 1 and new claim 48 support tliese limitations of new claim 32. Additional
support for claim 32 can be found at least on page 2 at line 8, where the system and
method is described as intended for use "in the human or other mammalian vagina/'

Applicants respectfully request that the Examiner contact the undersigned by
telephone with any question as to support for any element in any pending claim.

B. Additional Remarks on the Patentability of the Invention

Each of the claims now pending in the application comprises an entirely
intravaginally containable probe unit comprismg a two-way communication means with
an antenna, capable of transmitting to and receiving signals from a control unit,
wirelessly and in real time. Applicants submit that none of the prior art cited by the
Examiner discloses a system including an entirely intravaginally containable probe unit
comprising a two-way communication means with an antenna and capable of
simultaneously transmitting to and receiving signals from a separate control unit,
wirelessly and in real time. Where the prior art does disclose an intravaginally
containable communication means, that communication means (a) is not wireless, (b)

Page 19 of 2 1

AppUcaiion No. I0/O07;593
Preliminary Amendment Submincd With RCG Appiicarion
Reply to Ofllce Aclion Mailed 05^09/2007

cannot both transmit and receive signals, and/or (c) cannot both transmit to and receive
eohtfolling dgnals ffom & COntiOl unit simultaneously in ml time.

Applicants note that Guice refers to the problems in the prior art associated with
wireless signal transmission to and/or from a device buried deep within a mammalian
body, as within a vagina, which Applicants mentioned above and have overcome with
their invention.

• "For those telesensor implants 50, 51 and application environments where
the combination and tradeoffs of implant RF transmitter power, antenna
length, RF signal attenuation and propagation distortion by passage
tlirough tissue, receiver antenna and receiver quality, and other factors
result in an RF to signal too weak or too distorted to be detected at ranges
convenient for economic installation of receivers in the vicinity of the
cattle pens, an ear tag, surface mountable patch, collar, or other device
attached to the animal and containing or supporting either a simple RF
boost and relay capability 58, (e,g,, a transponder), or a signal detection,
processing, and transmission capability 58 may be employed to obtain the
additional range and other functions as described hereinafter." [0087]

• **a percutaneous implant which enables use of an external, exposed
antenna may offer significant offsetting advantages in terms of increased
transmit and reception range and other benefits/* [0155]

• "One key advantage of a percutaneous implant is that an antenna may be
exposed on the outside of an animal, thereby enabling use of a longer
antenna than it may [sic] desirable to implant inside an animal, and also
avoiding the attenuation and distortion of RF signals by the tissue of the
animal which is a problem at some frequencies/' [0181]

The limitations of the claims now pending in the application render the claimed
subject matter novel and non-obvious over the cited prior art.

No new matter has been entered in conjunction with the amendments to claims 1 ,
12, and 13 or new claims 20-72. Support for each of the elements of each of these
pending claims can be found in the original specification including the drawings and the
written description. The courtesy of a telephone interview is respectfully requested
should the Examiner have any question or concern relating to the patentability of
Applicants' invention.

Applicants believe that the application is now in condition for allowance and
respectfully request reconsideration of the allowability of Applicants' pending claims. In

Page 20 of 2 1

Application No. I0/007;)93
Preliminary Amcndmcni Submined With KCE Aj^iicaiion
Reply io Ofiice Action Mailed 03/09^07

view of the claim amendments and the remarks, further and fevorable consideration of
the i>fe$6rttly pending claims dnd th6 mly i^udnee of & Notice of Allowance with regard
to all pending claims are respectfully requested.

ROBERT W. BECKER & ASSCXTIATES
707 State Hwy 333, Suite B
Tijeras.NM 87059-7507
Telephone: (505) 286-35 1 1
Facsimile: (505) 286-3524

Respectfully submitted,

Robert W. Becker, Reg. 26,255
Attorney for Applicants

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